VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00832 Package ID: USCOURTS-cofc-1_18-vv-00832 Petitioner: Kimberly A. Purtill Filed: 2018-06-12 Decided: 2021-02-01 Vaccine: influenza Vaccination date: 2015-09-30 Condition: left shoulder injuries related to vaccine administration (SIRVA) Outcome: compensated Award amount USD: 50000 AI-assisted case summary: Kimberly A. Purtill filed a petition for compensation on June 12, 2018, alleging that she suffered left shoulder injuries related to vaccine administration (SIRVA) as a result of an influenza vaccine received on September 30, 2015. The respondent initially moved to dismiss, arguing that Ms. Purtill failed to provide evidence of the six-month severity requirement. However, the Chief Special Master denied this motion, finding that the evidence showed her injury persisted for more than six months. The respondent did not raise any other challenges to entitlement. On May 7, 2020, the Chief Special Master issued a Ruling on Entitlement, finding Ms. Purtill entitled to compensation for a Table SIRVA. The decision detailed how Ms. Purtill met all the criteria for SIRVA, including lack of prior condition, onset of pain within 48 hours of vaccination, pain limited to the affected shoulder, and no other condition explaining the symptoms. On December 4, 2020, the respondent filed a proffer agreeing to an award of $50,000.00, which Ms. Purtill accepted. On February 1, 2021, the court issued a Decision Awarding Damages, granting Ms. Purtill a lump sum payment of $50,000.00. Theory of causation field: Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_18-vv-00832-0 Date issued/filed: 2019-12-27 Pages: 8 Docket text: PUBLIC ORDER/RULING (Originally filed: 11/12/2019) regarding 31 Findings of Fact & Conclusions of Law, Signed by Chief Special Master Brian H. Corcoran. (ypb) Service on parties made. -------------------------------------------------------------------------------- Case 1:18-vv-00832-UNJ Document 34 Filed 12/27/19 Page 1 of 8 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 18-0832V UNPUBLISHED Chief Special Master Corcoran KIMBERLY A. PURTILL, Dated: November 12, 2019 Petitioner, v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Motion to Dismiss; Six Month HUMAN SERVICES, Residual Effects or Sequelae; Influenza (Flu) Vaccine; Shoulder Respondent. Injury Related to Vaccine Administration (SIRVA) Amy A. Senerth, Muller Brazil, LLP, Dresher, PA, for Petitioner. Robert Paul Coleman, III, U.S. Department of Justice, Washington, DC, for Respondent. ORDER DENYING MOTION TO DISMISS AND FINDING OF FACT ON SIX MONTH REQUIREMENT 1 On June 12, 2018, Kimberly Purtill filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.,2 (the “Vaccine Act”). An amended petition was filed on July 31, 2018 (ECF No. 9). In it, Petitioner alleges that she suffered a left shoulder injury related to vaccine administration (“SIRVA”) as a result of a September 30, 2015 influenza (“flu”) vaccine. Petition at 1. The case was assigned to the Special Processing Unit (“SPU”) of the Office of Special Masters. 1 Because this unpublished decision contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:18-vv-00832-UNJ Document 34 Filed 12/27/19 Page 2 of 8 Respondent has now filed a motion to dismiss the petition, alleging that Petitioner has failed to provide evidence to satisfy the six-month severity requirement set forth in Section 11(c)(1)(D)(i) of the Vaccine Act (ECF No. 25). For the reasons discussed below, Respondent’s motion is denied. I. Factual Background On September 30, 2015, Ms. Purtill, then a 53-year old virtual critical care supervisor and registered nurse, received a flu vaccine intramuscularly into her left arm. Petitioner’s Exhibit (“Pet. Ex.”) 1 at 1; 3 at 8. In her affidavit, Petitioner avers that she felt pain in her left shoulder “[i]mmediately after vaccination.” Pet. Ex. 5 at 1 ¶ 3. She averred that she expected the pain would go away but that instead it got worse. Id. On October 21, 2015, Petitioner reported to an urgent care center operated by her employer, Carolinas Health System. Pet. Ex. 3 at 1. Her chief complaint was that she had gotten a flu shot on September 30 and that her left shoulder joint was still “hurting a lot.” Id. She reported that she received her flu shot with a 20-gauge one inch needle in her left deltoid three weeks earlier. Id. The evening of the flu shot, she noticed mild aching pain in her left shoulder, and the pain had progressed since then. Id. She reported that the pain was worse with abduction and forward flexion of the left shoulder and was somewhat improved with Aleve. Id. She denied a history of left shoulder pain. Id. She was given prednisone. Id. at 2. A Work Status/Treatment Report, also dated October 21, 2015, indicated that Petitioner’s injury occurred on September 30, 2015. Pet. Ex. 2 at 1; 3 at 7. A Radiology Interpretation Requisition from the same date indicates that Petitioner had normal left shoulder studies. Pet. Ex. 3 at 5. The clinical indication for the studies was flu vaccine in Petitioner’s left arm four weeks earlier and complaints of pain for four weeks. Id. On November 16, 2015, Petitioner reported to Carolinas Healthcare System’s Employee Health Division and was examined by Dr. Larry Raymond. Pet. Ex. 3 at 8. She reported persisting and worsening left shoulder pain for six weeks due to a flu shot on September 30, 2015. Id. She reported that both abduction and adduction were quite painful. Id. She reported waking at night when she rolled over. Id. She reported that a steroid taper had eliminated the radiating pain that was reaching her left elbow but that local deltoid pain and tenderness remained. Id. Petitioner reported no prior left shoulder discomfort or similar reaction to a flu shot. Id. On examination, Dr. Raymond found that Petitioner exhibited evidence of left rotator cuff tendinitis, left deltoid myositis, and focal tenderness to palpation. Pet. Ex. 3 at 8. Dr. Raymond noted positive Neer’s and empty can impingement signs, as well as other signs of rotator cuff tendinitis. Id. Dr. Raymond assessed Petitioner with an “[a]dverse effect of influenza immunization with L deltoid myositis and brachial neuritis also involving rotator cuff (supraspinatus & infraspinatus).” Id. 2 Case 1:18-vv-00832-UNJ Document 34 Filed 12/27/19 Page 3 of 8 Dr. Raymond prescribed a non-steroidal anti-inflammatory drug (“NSAID”) and topical diclofenac gel. Pet. Ex. 3 at 8. He noted that Petitioner may need to be seen again in 1-2 weeks. Id. On March 23, 2016, Petitioner reported to Dr. Raymond for a follow up examination. Pet. Ex. 3 at 9. The record noted that she had left shoulder pain after a flu shot in the fall and got “quite a lot of relief” from a prednisone taper. Pain donning her shirt or rolling over in her sleep “got up to 8/10.” Id. The pain locations were recorded as “L retroclavicular, L forearm radiating up to shoulder, some L supraspinatus.” Id. The note continues, “No (sic) pain is gone except occ. 2 of 10 in” left supraspinatus area donning shirt. Id. I interpret the “no” in this sentence as meaning “now.” With this interpretation, the record indicates that as of March 23, 2016, Petitioner’s pain was gone, except for occasional relatively minor pain while putting on a shirt. On examination, Dr. Raymond noted “[n]o discomfort induced by ‘JAMA 2014’ maneuvers (painful arc and pressing dorsum of hands into thoracic spine). Pet. Ex. 3 at 9. Dr. Raymond summarized that, “[a]fter 4 months of pain, the steroid taper 40/day x 3 down to 5 mg/d over 10 days erased most of her pain.” Id. (emphasis added). He indicated a reluctance to prescribe more prednisone and noted that Petitioner did not want that either. Id. Dr. Raymond’s treatment plan noted that “shoulder rolls and other ROM exercises may help prolong her remission. If pain recurs, will refer her for PT.” Pet. Ex. 3 at 9. He noted that he did not think that an orthopedic referral would help at this time. Id. At the bottom of the page, underneath Dr. Raymond’s signature, there is a note stating, “Next seen @ Med OV for unrelated matter, 5/27/16, No mention of shoulder.” Id. In her supplemental affidavit, Petitioner averred that on March 23, 2016, she reported to Dr. Raymond “that following two courses of prednisone my left shoulder pain had mostly resolved, however, my range of motion was limited, my left arm strength was limited and I experienced increased pain with the use of my arm. I continued to take Aleve twice daily to control my symptoms, in addition to heat or ice and use of an over the counter TENS unit (transcutaneous electrical nerve stimulation).” Pet. Ex. 7 at ¶ 7. Petitioner reported that Dr. Raymond instructed her to perform home exercises and return if her pain increased. Id. at ¶ 8. Petitioner averred that she “did not return to Dr. Raymond as my pain leveled off, and I did not believe that anything further could be done to treat my left shoulder pain.” Id. at ¶ 9. On May 27, 2016, Petitioner was seen by physician assistant Timothy Kelley. Pet. Ex. 4 at 129. She reported that she would like to discontinue an anxiety/depression medication secondary to possible gastrointestinal issues. Id. There is no indication at this time that she reported shoulder pain, and no musculoskeletal examination was recorded. Id. at 129-146. On September 2, 2016, Petitioner was seen by physician assistant Timothy Kelley for anxiety. Pet. Ex. 4 at 61. There is again no indication that she reported shoulder pain, 3 Case 1:18-vv-00832-UNJ Document 34 Filed 12/27/19 Page 4 of 8 and no musculoskeletal examination was recorded. Id. at 61-78. The page following this record is an undated request for medical exemption from the influenza vaccination for 2016-2017 indicating that Petitioner had “a contraindication that warrant[ed] a medical exemption from the influenza vaccine.” Pet. Ex. 4 at 65. The form is signed by physician assistant Kelley. Id. On October 31, 2016, Petitioner reported to Dr. Grant Campbell for an annual well women examination. Pet. Ex. 6 at 7. There is no indication that she reported shoulder pain. Id. at 7-23. In the musculoskeletal section of the review of systems, the record states “Negative.” Pet. Ex. 6 at 7. In the physical examination section, the record states, “Normal range of motion, No deformity.” Id. On November 29, 2016, Petitioner reported to Dr. Timothy Hodges complaining of bilateral scapular pain, bilateral flank pain, and intractable headache. Pet. Ex. 4 at 80. Petitioner reported bilateral scapular pain and flank pain since November 1, 2016. Id. The scapular tenderness was not made worse by flexion, extension, or lateral rotation, and was worst when she was recumbent lying in bed. Id. On examination, she was found to have “[b]ilateral trapezius spasm with palpable tenderness.” Id. at 82. She was diagnosed with chronic scapular pain and instructed to follow up in one to two weeks. Id. Chest radiology studies were done and found to be normal on November 29, 2016. Pet. Ex. 4 at 95. The testing was done due to “upper back pain for about 1 month.” Id. Petitioner was excused from work for the day. Id. at 113. In her supplemental affidavit, Petitioner stated, “I did discuss my ongoing left shoulder pain with my primary care physician at routine visits.” Pet. Ex. 7 at ¶ 9. She does not provide dates of these discussions and does not indicate the nature and resolution of the discussions. The only primary care record that refers to shoulder pain is the November 29, 2016 visit with Dr. Hodges for bilateral scapular pain, Pet. Ex. 4 at 80. II. Relevant Procedural History Petitioner filed with her petition medical records and an affidavit as Pet. Exs. 1-5 (ECF No. 1) and filed a Statement of Completion on June 14, 2018 (ECF No. 5). Following the initial status conference on July 23, 2018, Petitioner was directed to file additional medical records (ECF No. 8). On July 31, 2018, Petitioner filed an amended petition, additional medical records, and a Statement of Completion (ECF Nos. 9-11). On April 8, 2019, Respondent filed a status report stating that he had requested from Petitioner that she file proof that she satisfied the six-month severity requirement to demonstrate entitlement to compensation (ECF No. 19). On April 23, 2019, Petitioner was directed to file evidence demonstrating that she suffered the effects of her injury for at least six months and an amended Statement of Completion (ECF No. 20). On the 4 Case 1:18-vv-00832-UNJ Document 34 Filed 12/27/19 Page 5 of 8 same day, April 23, 2019, Petitioner filed an amended Statement of Completion (ECF No. 21). Petitioner stated: On March 23, 2016, five (5) months and twenty-three (23) days following receipt of the influenza vaccine, Petitioner returned to Dr. Raymond with ongoing left shoulder pain. At that time, she reported, “Pain donning shirt or rolling over in sleep got up to an 8/10.” At that time Dr. Raymond recommended home-exercises. There are no additional medical records. Petitioner’s Amended Statement of Completion, filed April 23, 2019 (ECF No. 21). On July 31, 2019, Respondent filed a Rule 4(c) report and motion to dismiss (ECF Nos. 24, 25). Respondent argued that Petitioner was not entitled to compensation because she had not satisfied the six month severity requirement. Rule 4(c) report at 4. Respondent stated that although Petitioner attended medical appointments outside of the six-month timeframe, “at none of those visits did she mention any left shoulder complaints. See Ex. 4 at 80-86, 95-96, 109, 115-119, 129-131.” Id. at 4-5. Respondent further noted that at Petitioner’s March 23, 2016 visit, Dr. Raymond “indicated that petitioner’s condition was much improved and that she did not require any additional medication.” Id. at 5 (citing Pet. Ex. 3 at 9). Thus, Respondent asserted that there was an “absence of any objective contemporaneous evidence that petitioner suffered from left shoulder pain more than six months after the September 30. 2015 vaccine was administered” and thus had failed to demonstrate entitlement to compensation. Id. at 5. Thus, Respondent argued that the petition should be dismissed. Id. On August 16, 2019, Petitioner filed a supplemental affidavit, Pet. Ex. 7, and a response opposing the motion to dismiss (ECF Nos. 27, 28). Petitioner argued that respondent’s motion to dismiss should be denied because “the evidence submitted demonstrates by preponderant evidence that her left shoulder injuries continued through March 30, 2016.” Petitioner’s Response at 1. Petitioner asserted that pursuant to Court of Federal Claims Rule 56(a) and Vaccine Rule 8(d), the court should enter judgment in favor of a moving party if there is no genuine dispute as to any material fact and the moving party is entitled to judgment as a matter of law. Id. at 3. Petitioner argued, “[d]ismissal is not appropriate if it appears the parties reasonably contest the length of time that petitioner has suffered from the effects of his alleged vaccine injury.” Id. at 4. Petitioner asserted that her medical records and affidavits established that it was more likely than not that she suffered the residual effects of her left shoulder injury for at least six months after her flu shot. Petitioner’s Response at 4. Petitioner argued that residual effects are “symptoms manifested due to the vaccine related injury” and that 5 Case 1:18-vv-00832-UNJ Document 34 Filed 12/27/19 Page 6 of 8 “[d]ischarge from medical care does not necessarily indicate there are no residual effects.” Id. Petitioner argued that her medical records reflected that on March 23, 2016, five months and 24 days following her vaccination, she reported that a steroid taper “erased . . . most of her [left shoulder] pain.” Petitioner’s Response at 5 (emphasis in original). Petitioner argued that in this context, the use of the term “most” implied that not all of her left shoulder pain had resolved. Id. Petitioner asserted that her affidavit corroborates this, indicating that while a second taper of steroids improved her symptoms, she still had limited range of motion and weakness in her left shoulder. Id. Petitioner acknowledged that her medical records did not corroborate all of her symptoms, but Dr. Raymond’s records noted some residual symptoms of her left shoulder pain. Id. Petitioner argued that her affidavit, as supported by her medical records, demonstrated by preponderant evidence that she suffered the residual effects of her injury for at least six months. Id. III. Relevant Legal Standards Under the Vaccine Act, a petition for compensation must contain “supporting documentation, demonstrating that the person who suffered [a vaccine related injury] ... suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine.” Vaccine Act § 11(c)(1)(D)(i). The burden of establishing, by a preponderance of the evidence, the persistence of a vaccine-caused injury for longer than six months is borne by Petitioner. Vaccine Act § 13(a)(1)(A); Song v. Sec'y of Health & Human Servs., 31 Fed. Cl. 61, 65– 66 (1994), aff'd, 41 F.3d 1520 (Fed. Cir. 1994). A Petitioner cannot establish the length or ongoing nature of an injury merely through self-assertion unsubstantiated by medical records or medical opinion. Vaccine Act § 13(a)(1)(A). A special master must consider, but is not bound by, any diagnosis, conclusion, judgment, test result, report, or summary concerning the nature, causation, and aggravation of Petitioner’s injury or illness that is contained in a medical record. Vaccine Act § 13(b)(1). “Medical records, in general, warrant consideration as trustworthy evidence. The records contain information supplied to or by health professionals to facilitate diagnosis and treatment of medical conditions. With proper treatment hanging in the balance, accuracy has an extra premium. These records are also generally contemporaneous to the medical events.” Curcuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). IV. Analysis The purpose of the Vaccine Act is to award “vaccine-injured persons quickly, easily, and with certainty and generosity.” Weddel v. Sec’y of Health & Human Servs., 100 F. 3d 929, 932 (Fed. Cir. 1996) (quoting H.R. Rep. No. 99-908, at 3 (1986)). The Act was meant to remedy the problem that “for the relatively few who are injured by vaccines – through no fault of their own – the opportunities for redress and restitution [were] limited, 6 Case 1:18-vv-00832-UNJ Document 34 Filed 12/27/19 Page 7 of 8 time consuming, expensive, and often unanswered.” Cloer v. Sec’y of Health & Human Servs., 654 F.3d 1322, 1325 (Fed. Cir. 2011) (en banc) (quoting H.R. Rep. No. 99-908, at 6 (1986)). As a result, the program places some emphasis on speed and efficiency, especially in close cases. The Vaccine Act requires that a Petitioner demonstrate that “residual effects or complications” of a vaccine related injury continued for more than six months. Vaccine Act § 11(c)(1)(D)(i). “[T]he fact that a Petitioner has been discharged from medical care does not necessarily indicate that there are no remaining or residual effects from her alleged injury.” Morine v. Sec’y of Health & Human Servs., No. 17-1013, 2019 WL 978825, at *4 (Fed. Cl. Spec. Mstr. Jan. 23, 2019); see also Herren v. Sec’y of Health & Human Servs., No. 13-1000V, 2014 WL 3889070, at *3 (Fed. Cl. Spec. Mstr. July 18, 2014) (“a discharge from medical care does not necessarily indicate there are no residual effects”). In another SPU case, where a Petitioner’s last treatment was at five months and nine days, the Petitioner was found to meet the six month requirement. Schafer v. Sec’y of Health & Human Servs., No. 16-0593V, 2019 WL 5849524 (Fed. Cl. Spec. Mstr. Aug. 28, 2019). In that case, the special master noted that it was unlikely “that petitioner’s shoulder symptoms would have resolved within 22 days.” Id. at *7. In this case, it is undisputed that Petitioner received a flu vaccination on September 30, 2015 in her left deltoid. The parties have not raised any dispute concerning the onset of Petitioner’s left shoulder pain and there is preponderant evidence that the onset of her pain was immediate. The parties have not disputed that Petitioner was seen by Dr. Raymond on March 23, 2016, seven days short of the six-month period. In order for Petitioner to establish more than six months of residual effects, she must demonstrate that her residual symptoms continued until at least one week after her March 23, 2016 appointment with Dr. Raymond. Respondent emphasizes that at the March 23, 2016 appointment Petitioner’s condition was greatly improved and that medication was no longer needed. Rule 4(c) report at 5. Petitioner, however, focuses on Dr. Raymond’s note indicating that most, and thus by implication, not all, of Petitioner’s pain was erased by the steroid taper. The most persuasive evidence concerning Petitioner’s condition on March 23, 2016 is Dr. Raymond’s note that Petitioner’s “pain [was] gone except occ. 2 of 10 . . . donning shirt.” Pet. Ex. 3 at 9 (emphasis added). This implication of this is that Petitioner’s pain was not completely gone, since she was still experiencing occasional pain getting dressed as of March 23, 2016. This is supported by the note cited by Petitioner indicating that most of her pain was erased by the steroid taper. Pet. Ex. 3 at 9. This is further supported by Petitioner’s statement in her supplemental affidavit that she reported on March 23, 2016, that her left shoulder pain had mostly resolved and that she experienced increased pain with the use of her arm. Pet. Ex. 7 at ¶ 7. Moreover, eight months later, on November 29, 2016, she was seen by her primary care physician for bilateral scapular pain. Pet. Ex. 4 at 80. Petitioner’s November 29, 7 Case 1:18-vv-00832-UNJ Document 34 Filed 12/27/19 Page 8 of 8 2016 appointment for shoulder pain further suggests that she continued to suffer lingering effects of her injury in the interim period. Petitioner has further explained why she did not return to Dr. Raymond after the March 23, 2016 visit – her pain had leveled off (even if some remained) and she did not think any further treatment was available. Id. at ¶ 9. This is consistent with Dr. Raymond’s reluctance to prescribe further treatment on March 23, 2016, when he indicated he did not want to prescribe more prednisone, did not think an orthopedic referral would help, and suggested that she continue home exercises. Pet. Ex. 3 at 9. Taken as a whole, this evidence supports a finding that as of March 23, 2016, Petitioner was still experiencing occasional and minimal residual symptoms, including left shoulder pain while getting dressed. Her treating physician considered further treatment options but determined that further treatment was not warranted at that time. Thus, I find it more likely than not that a shoulder injury that was still causing occasional pain after five months and twenty-three days (which is 175 days) would not fully resolve within the following week. Therefore, I find it more likely than not that Petitioner suffered the residual effects of her left shoulder injury for more than six months (if barely). I do not make this finding based solely on Petitioner’s assertions, but also on corroborating medical records, specifically the record of her March 23, 2016 visit with Dr. Raymond, Pet. Ex. 3 at 9, and the record of her November 29, 2016 appointment, Pet. Ex. 4 at 80. Taken as a whole, the record establishes that she suffered the residual effects of her injury for more than six months. This is a close case. The evidence supporting residual effects for more than six months barely tips in Petitioner’s favor. However, “[i]n the Vaccine Program, petitioners are accorded the benefit of close calls.” Roberts v. Sec’y of Health & Human Servs., No. 09-427V, 2013 WL 5314698, at *10 (Fed. Cl. Spec. Mstr. Aug. 29, 2013). V. Conclusion For the reasons stated above, I DENY respondent’s motion. I find, based on the record as a whole, that Petitioner has established that she suffered the residual effects of her vaccine-related injury for at least six months. Respondent shall file, by no later than Thursday, December 12, 2019, a status report indicating how he intends to proceed in this case in light of this decision. IT IS SO ORDERED. s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 8 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_18-vv-00832-1 Date issued/filed: 2020-06-08 Pages: 6 Docket text: PUBLIC ORDER/RULING (Originally filed: 05/07/2020) regarding 39 Ruling on Entitlement Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:18-vv-00832-UNJ Document 42 Filed 06/08/20 Page 1 of 6 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 18-0832V UNPUBLISHED KIMBERLY A. PURTILL, Chief Special Master Corcoran Petitioner, Filed: May 7, 2020 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Ruling on Entitlement; Table Injury; HUMAN SERVICES, Influenza (Flu) Vaccine; Shoulder Injury Related to Vaccine Respondent. Administration (SIRVA) Amy A. Senerth, Muller Brazil, LLP, Dresher, PA, for petitioner. Robert Paul Coleman, III, U.S. Department of Justice, Washington, DC, for respondent. RULING ON ENTITLEMENT1 On June 12, 2018, Kimberly A. Purtill filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine Act”). Petitioner alleges that she suffered left shoulder injuries related to vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccine received on September 30, 2015. Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. On July 31, 2019, Respondent filed his Rule 4(c) Report (ECF No. 24) and a motion to dismiss (ECF No. 25). Respondent requested dismissal based upon the contention that Petitioner had failed “to provide evidence to satisfy the six-month severity requirement provided by Section 11(c)(1)(D)(i) of the Vaccine Act.” Motion to Dismiss at 1 Because this unpublished ruling contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the ruling will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:18-vv-00832-UNJ Document 42 Filed 06/08/20 Page 2 of 6 *1. Although Petitioner had alleged that her injuries lasted more than six months, she “included no citation for this statement.” Rule 4(c) Report at *4. Respondent conceded that Petitioner had attended appointments with medical providers outside of the six-month timeframe, but asserted that “at none of those visits did she mention any left shoulder complaints.” Id. at *4-5. In addition, at Petitioner’s last visit for shoulder pain just short of six months after her injury, her doctor “indicated that petitioner’s condition was much improved and that she did not require any additional medication.” Id. at *5. Accordingly, Respondent argued that there was no objective contemporaneous evidence that Petitioner had suffered from left shoulder pain for more than six months. Id. Respondent raised no other challenges to Petitioner’s success in establishing a Table SIRVA claim. On November 12, 2019, I issued an order denying Respondent’s motion to dismiss, and making a factual finding that Petitioner had satisfied the six-month requirement. Order Denying Motion to Dismiss and Finding of Fact on Six Month Requirement, issued Nov. 12, 2019 (ECF No. 31). I found that the evidence showed that Petitioner was seen by her doctor seven days short of the end of the six-month period, and that at this appointment the record indicated that most of Petitioner’s pain was gone – allowing the inference that it was not completely gone. Id. at *7. I found that more likely than not, her injury did not fully resolve within the following week. Id. at *7-8. On this basis, and while it was a close case, I found that Petitioner had established that she had suffered the residual effects of her injury for more than six months. Id. at *8. Respondent was then directed to file a status report indicating how he intended to proceed. Id. at *8. On December 12, 2019, Respondent filed a status report stating that he intended to continue to defend this case, but not identifying any reasons why I should not find that Petitioner is entitled to compensation. Respondent’s Status Report, filed Dec. 12, 2019 (ECF No. 33). On February 6, 2020, a telephonic conference was held to discuss the matter’s status. Following the status conference, Respondent was directed to file either an amended Rule 4(c) Report or general status report indicating how Respondent wished to proceed. Scheduling Order, issued Feb. 6, 2020 (ECF No. 37). On February 20, 2020, Respondent filed a status report stating that he did “not have anything to add to his previously filed Rule 4(c) Report.” Respondent’s Status Report, filed Feb. 20, 2020 (ECF No. 38). In this case, Respondent’s sole objection involved whether Petitioner had provided sufficient evidence to meet the six month requirement. While this was a close case, I ruled in Petitioner’s favor on this issue. No other issues related to entitlement have been raised. After a review of the entire record, I find that Petitioner is entitled to compensation. 2 Case 1:18-vv-00832-UNJ Document 42 Filed 06/08/20 Page 3 of 6 I. Factual Findings and Ruling on Entitlement A. Legal Standards Before compensation can be awarded under the Vaccine Act, a petitioner must demonstrate, by a preponderance of evidence, all matters required under Section 11(c)(1), including the factual circumstances surrounding her claim. Section 13(a)(1)(A). In making this determination, the special master or court should consider the record as a whole. Section 13(a)(1). Petitioner’s allegations must be supported by medical records or by medical opinion. Id. To resolve factual issues, the special master must weigh the evidence presented, which may include contemporaneous medical records and testimony. See Burns v. Sec'y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special master must decide what weight to give evidence including oral testimony and contemporaneous medical records). Contemporaneous medical records are presumed to be accurate. See Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993). To overcome the presumptive accuracy of medical records testimony, a petitioner may present testimony which is “consistent, clear, cogent, and compelling.” Sanchez v. Sec'y of Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Human Servs., No. 90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)). In addition to requirements concerning the vaccination received, the duration and severity of petitioner’s injury, and the lack of other award or settlement,3 a petitioner must establish that she suffered an injury meeting the Table criteria, in which case causation is presumed, or an injury shown to be caused-in-fact by the vaccination she received. § 11(c)(1)(C). The most recent version of the Table, which can be found at 42 C.F.R. § 100.3, identifies the vaccines covered under the Program, the corresponding injuries, and the time period in which the particular injuries must occur after vaccination. Section 14(a). Pursuant to the Vaccine Injury Table, a SIRVA is compensable if it manifests within 48 hours of the administration of an influenza vaccine. 42 C.F.R. § 100.3(a)(XIV)(B). The criteria establishing a SIRVA under the accompanying QAI are as follows: Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests as shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. 3 In summary, a petitioner must establish that she received a vaccine covered by the Program, administered either in the United States and its territories or in another geographical area but qualifying for a limited exception; suffered the residual effects of her injury for more than six months, died from her injury, or underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected an award or settlement for her injury. See § 11(c)(1)(A)(B)(D)(E). 3 Case 1:18-vv-00832-UNJ Document 42 Filed 06/08/20 Page 4 of 6 SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis (even if the condition causing the neurological abnormality is not known). A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following: (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection; (ii) Pain occurs within the specified time frame; (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and (iv) No other condition or abnormality is present that would explain the patient’s symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy). 42 C.F.R. § 100.3(c)(10). B. Factual Findings Regarding QAI Criteria for Table SIRVA After a review of the entire record, I find that a preponderance of the evidence demonstrates that Petitioner has satisfied the QAI requirements for a Table SIRVA. 1. Prior Condition The first QAI requirement for a Table SIRVA is lack of a history revealing problems associated with the affected shoulder which were experienced prior to vaccination and would explain the symptoms experienced after vaccination. 42 C.F.R. § 100.3(c)(10)(i). Respondent has not contested that Petitioner meets this criterion, and I find that she has demonstrated a lack of history of pain, inflammation, or dysfunction of her left shoulder that would explain her symptoms. See Ex. 7 at ¶ 4; Ex. 4. 2. Onset of Pain Pursuant to Section 13(b)(2) of the Vaccine Act, a special master may find that the first symptom or manifestation of onset occurred within the time period set forth in the Table even if the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such period. In my November 12, 2019 Order, I determined that the onset of petitioner’s left shoulder injuries occurred immediately after her September 30, 2015 influenza vaccination based on medical records and petitioner’s testimony and affidavit. Order on 4 Case 1:18-vv-00832-UNJ Document 42 Filed 06/08/20 Page 5 of 6 Motion to Dismiss and Finding of Fact, issued Nov. 12, 2019, at *7 (ECF No. 31); see also Ex. 2 at 1-2 (listing date of injury as 9/30/15 and stating the reason for visit as “got a flu shot on Sept 30th, still left shoulder [joint] is hurting a lot”); Ex. 3 at 1(noting that Petitioner complained of “continued left shoulder aching pain for the past 3 weeks. Patient states she [received] her flu shot in her left deltoid 3 weeks ago . . . that evening she started noticing mild aching pain in the left shoulder and states pain has progressed since.”). Thus, petitioner has demonstrated by a preponderance of the evidence that her injury occurred within 48 hours, the time specified in the Table for a SIRVA. 3. Scope of Pain and Limited ROM Respondent has not contested that Petitioner meets this criterion. In addition, the medical records document symptoms only in Petitioner’s left shoulder following her vaccine. 4 Ex. 2 at 1, 2. I thus find that Petitioner has demonstrated by a preponderance of the evidence that her pain and reduced range of motion were limited to the shoulder in which the intramuscular vaccine was administered. 4. Other Condition or Abnormality The last QAI criteria for a Table SIRVA states that there must be no other condition or abnormality which would explain a petitioner’s current symptoms. 42 C.F.R. § 100.3(c)(10)(iv). There is no evidence that Petitioner suffered any other condition which would explain her symptoms of pain and limited ROM in her left shoulder. Nor has Respondent identified any such other condition or abnormality. I find the record contains preponderant evidence establishing that there is no other condition or abnormality which would explain the symptoms of Petitioner’s left shoulder injury. C. Other Requirements for Entitlement In addition to establishing a Table injury, a petitioner must also provide preponderant evidence of the additional requirements of Section 11(c). Respondent does not dispute that Petitioner has satisfied these requirements in this case, and the overall record contains preponderant evidence to fulfill these additional requirements. The record shows that Petitioner received the flu vaccine intramuscularly in her left arm on September 30, 2015 at a health clinic located in Charlotte, North Carolina. Ex. 1 at 1; Ex. 5 at ¶ 2; see Section 11(c)(1)(A) (requiring receipt of a covered vaccine); Section 11(c)(1)(B)(i)(I) (requiring administration within the United States or its territories). There is no evidence that Petitioner has collected a civil award for her injury. Ex. 5 at ¶ 6; Section 11(c)(1)(E) (lack of prior civil award). 4 I am aware that Petitioner suffered from bilateral scapular pain over a year after vaccination. Ex. 4 at 80. On examination, she was found to have bilateral “trapezius spasm with palpable tenderness.” Id. at 82. This does not outweigh the remaining extensive evidence of symptoms only in Petitioner’s left shoulder following vaccination. 5 Case 1:18-vv-00832-UNJ Document 42 Filed 06/08/20 Page 6 of 6 As stated in the previous section, I have found that the onset of Petitioner’s left shoulder pain was immediate and thus, within 48 hours of vaccination. See 42 C.F.R. § 100.3(c)(10)(ii) (setting forth this QAI requirement). This finding also satisfies the requirement that Petitioner’s first symptom or manifestation of onset occur within the time frame listed on the Vaccine Injury Table. 42 C.F.R. § 100.3(a)(XIV)(B) (listing a time frame of 48 hours for a Table SIRVA following receipt of the influenza vaccine). Therefore, Petitioner has satisfied all requirements for a Table SIRVA. The last criteria which must be satisfied by Petitioner involves the duration of her SIRVA. For compensation to be awarded, the Vaccine Act requires that a petitioner suffer the residual effects of his or her left shoulder injury for more than six months. See Section 11(c)(1)(D)(i) (statutory six-month requirement). But in my November 12, 2019 Order and Fact Ruling, I found that Petitioner had established that she suffered the residual effects of her injury for more than six months. Thus, this requirement is also met. Based upon all of the above, Petitioner has established that she suffered a Table SIRVA. Additionally, she has satisfied all other requirements for compensation. I therefore find that Petitioner is entitled to compensation in this case. In view of Respondent’s position and the evidence of record, I find that Petitioner is entitled to compensation. IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 6 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_18-vv-00832-2 Date issued/filed: 2021-02-01 Pages: 4 Docket text: PUBLIC DECISION (Originally filed: 12/04/2020) regarding 49 DECISION Stipulation/Proffer Signed by Chief Special Master Brian H. Corcoran. (sw) Service on parties made. -------------------------------------------------------------------------------- Case 1:18-vv-00832-UNJ Document 53 Filed 02/01/21 Page 1 of 4 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 18-0832V UNPUBLISHED KIMBERLY A. PURTILL, Chief Special Master Corcoran Petitioner, Filed: December 4, 2020 v. Special Processing Unit (SPU); SECRETARY OF HEALTH AND Damages Decision Based on Proffer; HUMAN SERVICES, Influenza (Flu) Vaccine; Shoulder Injury Related to Vaccine Respondent. Administration (SIRVA) Amy A. Senerth, Muller Brazil, LLP, Dresher, PA, for petitioner. Mallori Browne Openchowski, U.S. Department of Justice, Washington, DC, for respondent. DECISION AWARDING DAMAGES1 On June 12, 2018, Kimberly A. Purtill filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10, et seq.2 (the “Vaccine Act”). Petitioner alleges that she suffered left shoulder injuries related to vaccine administration (“SIRVA”) as a result of an influenza (“flu”) vaccine received on September 30, 2015. Petition at 1. The case was assigned to the Special Processing Unit of the Office of Special Masters. On May 7, 2020, a ruling on entitlement was issued, finding Petitioner entitled to compensation for SIRVA. On December 4, 2020, Respondent filed a proffer on award of compensation (“Proffer”) indicating Petitioner should be awarded $50,000.00. Proffer at 1. In the Proffer, Respondent represented that Petitioner agrees with the proffered award. 1 Because this unpublished decision contains a reasoned explanation for the action in this case, I am required to post it on the United States Court of Federal Claims' website in accordance with the E- Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). This means the decision will be available to anyone with access to the internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy. If, upon review, I agree that the identified material fits within this definition, I will redact such material from public access. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). Case 1:18-vv-00832-UNJ Document 53 Filed 02/01/21 Page 2 of 4 Id. Based on the record as a whole, I find that Petitioner is entitled to an award as stated in the Proffer. Pursuant to the terms stated in the attached Proffer, I award Petitioner a lump sum payment of $50,000.00 in the form of a check payable to Petitioner. This amount represents compensation for all damages that would be available under § 15(a). The clerk of the court is directed to enter judgment in accordance with this decision.3 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Chief Special Master 3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice renouncing the right to seek review. 2 Case 1:18-vv-00832-UNJ Document 53 Filed 02/01/21 Page 3 of 4 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS KIMBERLY A. PURTILL, Petitioner, No. 18-832V Chief Special Master Corcoran v. SPU SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. RESPONDENT’S PROFFER ON AWARD OF COMPENSATION I. Compensation for Vaccine Injury-Related Items On November 12, 2019, Chief Special Master Corcoran issued a Fact Ruling, finding that petitioner satisfied the six-month severity requirement set forth in Section 11(c)(1)(D)(i) of the Vaccine Act. Thereafter, on May 7, 2020, Chief Special Master Corcoran issued a Ruling on Entitlement finding that petitioner was entitled to vaccine compensation for her Shoulder Injury Related to Vaccine Administration (“SIRVA”). Based on the evidence of record, respondent proffers that petitioner should be awarded $50,000.00.1 This amount represents all elements of compensation to which petitioner would be entitled under 42 U.S.C. § 300aa-15(a).2 Petitioner agrees. 1 The parties have no objection to the amount of the proffered award of damages. However, respondent reserves his right, pursuant to 42 U.S.C. § 300aa-12(e), to seek review of the Chief Special Master’s May 7, 2020 entitlement decision. 2 Should petitioner die prior to entry of judgment, the parties reserve the right to move the Court for appropriate relief. In particular, respondent would oppose any award for future lost earnings and future pain and suffering. Case 1:18-vv-00832-UNJ Document 53 Filed 02/01/21 Page 4 of 4 II. Form of the Award The parties recommend that compensation provided to petitioner should be made through a lump sum payment of $50,000.00, in the form of a check payable to petitioner. Petitioner agrees. Petitioner is a competent adult. Evidence of guardianship is not required in this case. Respectfully submitted, JEFFREY BOSSERT CLARK Acting Assistant Attorney General C. SALVATORE D’ALESSIO Acting Director Torts Branch, Civil Division CATHARINE E. REEVES Deputy Director Torts Branch, Civil Division ALEXIS B. BABCOCK Assistant Director Torts Branch, Civil Division s/ Mallori B. Openchowski MALLORI B. OPENCHOWSKI Trial Attorney Torts Branch, Civil Division U.S. Department of Justice P.O. Box 146, Ben Franklin Station Washington, DC 20044-0146 Tel.: (202) 305-0660 DATED: December 4, 2020 2